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With the sp tumbling shareholders are right to be wary but the results so far attest to the superiority of Genedrive's tests:

"This validation study of the Genedrive CYP2C19 ID Kit demonstrates that this rapid point-of-care assay has an analytical performance with a sensitivity and specificity of 100% (95% CI, 95.0%–100% and 97.2%–100%, respectively). During this assessment, the Genedrive CYP2C19 ID Kit performed better than the widely used laboratory reference test, with a superior accuracy and a lower failure rate. This robust analytical performance, coupled with the fact that a result can be generated at the point of care in approximately 1 hour, means the system has several distinct advantages over existing laboratory-based and comparator POCT genetic testing approaches.....

The Genedrive technology has previously been implemented in the neonatal intensive care unit, a hyperacute setting, to avoid aminoglycoside-induced hearing loss.2 The fact that this has been implemented successfully, requiring minimal training, demonstrates the ability of this platform to provide genetics at the point of need, democratizing access to pharmacogenetic-guided therapy."

https://www.sciencedirect.com/science/article/pii/S152515782400312X

Just following on from Junior's post, I was one of those who contacted the PR company last week. The responses were the usual generalities but a couple of points of note.

1) I questioned the optimistic timelines put out by the company which fail to materialise. Response: "The Company judges the timelines based on their relationships with third parties and are not in control of when these timelines are met. They can give guidance, but there are no guarantees on this." By third party relationships they are clearly referring primarily to the NHS. I do wonder how much follow up the company does if a timeline is not met.

2)Re the pilot test results: "The CYP2C19 NHSE pilot is run by NHSE and genedrive are not aware of information other than what is public currently." That is good news as they are not aware of bad news! Hopefully insiders are not either!

The dilemma is this. If the big news is expected in just over two weeks time we would have expected the sp to be rising in anticipation but instead it is going south with some big sell offs. So we have the following possibilities:

1)There is bad news re the pilot that has leaked out.

2)The impatient getting fed up with waiting for the implementation guide since we were told the pilot was finishing in April and national commissioning would be by then.

3)The snowball effect where a few big sells push the sp down and others follow suit.

4)General investor nerves.

5)Fears of a further fund raise.

6)A leak of a further fund raise.

7)A large shareholder selling out pushing the sp south.

Hopefully the news in two weeks time will be positive and hopefully we shall see better days again.

"It all points to a rather unhappy workplace and not a meaningful scenario to develop one’s career path." I did some digging and , sad to say, came up with this:

Assay Development Scientist (Former Employee) -13 April 2022 "Chaotic management with no plan, condescending co workers and generally demotivating environment. As good as products are that they make, Unless you’re into having no plan and changing at the last minute. Also pay is terrible considering the sheer amount of work you’re expected to do."

Chief Commercial Officer (Former Employee) - 24 October 2022 "Some great people, interesting products but the CEO interferes in decisions that directly influence the direction and success of the company. Statements of support without actual follow through, promises of rewards that never materialise and favouritism make what could be a great company a difficult and stressful place to work, with very high turnover resulting from this."

Scientist (Former Employee) - 21 June 2023 "So much potential but management have no idea how to do it. Toxic work culture promoting blame with minimal assistance if you feel overwhelmed, stressed or simply want a second opinion. Avoid"

Working at Genedrive Plc: Employee Reviews | Indeed.com

Not a good look but hopefully things have improved under the new CEO and the products themselves seem to be favourably regarded by these disgruntled ex employees with comments such as ".As good as products are that they make", and "interesting products."

Someone said a week ago that the sp should rise steadily up to the expected Implementation guidance publication date, around 15th August . The sp then was 1.40p mid. It is now 1.325 mid, a drop of 5%. So, sadly, that rise is not happening. I hope this does not mean that bad news has been leaked. I saw that happen with SNG which dropped steadily before bad news finally arrived and then it sank like a stone. Hopefully with GDR it is simply down to investor nerves.

We shall likely know in three weeks time.🙂

Warren Buffet once said, "Someone is sitting in the shade today because someone planted a tree along time ago." It feels a bit like that with Genedrive except we're not yet sitting in the shade. As we wait for the implementation guide for CYP2C19 followed by national commissioning I thought I'd look back at the timeline for Genedrives other product, MT-RNR1, which truly is the tree planted long ago. Some might be surprised at how long things have taken.

1) CE marking obtained 18/11/19

2)"The product is due to be launched on a targeted basis in UK and Ireland at the end of 2020 with full commercial roll out planned for June 2021". 17/11/20

3)AIHL trials successfully completed in June 2021

4)New generation Genedrive System platform, developed to support the commercial launch of the MT-RNR1 ID Kit, receives CE-IVD marking in anticipation of launch into the UK and EU. 29/9/21

5)First six installations of MT-RNR1 deployed to Manchester University NHS Foundation Trust.18/3/22

6)NICE starts an evaluation of the MT-RNR1 test via their Diagnostics Assessment Programme.16/6/22

7)GDR commences engagement with the FDA to progress the regulatory approval of the MT-RNR1 ID Kit into the USA. 5/10/22

8)NICE preliminarily recommends that MT-RNR1 ID Kit can be used by the NHS following the evidence review as part of their Early Value Assessment (EVA) Programme. 9/2/23

9)MT-RNR1 ID Test receives positive final recommendation by NICE 30/3/23

10)Initial overseas orders. 20/12/23

11) initial orders received for the MT-RNR1 Kit from a further five UK hospitals in the Greater Manchester region 24/5/24

12)"FDA submission for MT-RNR1 scheduled for late 2026". Gino, Investors Forum, June 2025

The progress of the CYP2C19 kit has been a lot faster and hopefully the wait for national commissioning will not be long delayed once we get the implementation guide "soon".

In the current heat wave, maybe then we can enjoy the shade.🙂

Jimi, Whilst I have great respect for the majority of your posts, the date of the implementation guide for CYP2C19 seems to be a very movable feast! From your previous posts:

Additionally the CYP2C19 testing implementation guide and toolkit from the NHS pilot is expected anytime now 2/4/25

The big news due any day is the NHS Pilot implementation guide. 2/5/25

The results of the pilot (due any day) 23/5/25

Implementation guide & national commissioning decision due any day now. 6/6/25

Now, a third of the way through July and we're still waiting. 🙂

Sadly the company has a history of long delays and over optimistic time lines. " Pre-submission process ongoing with the Food and Drug Administration ("FDA") to determine regulatory process and requirements to place AIHL into the American market" That was back in November 2023!!

For the sceptics, a reminder of the recommendation of NICE in April of last year:

"There are likely to be considerable barriers to implementing laboratory-based testing for everyone who has had an ischaemic stroke or TIA. If laboratory-based testing is not available, or it will take a long time to develop capacity to provide it, then point-of-care tests could be used. So, the Genedrive CYP2C19 ID Kit should be used when laboratory-based testing is not available."

What we're waiting for now, and it should as others have pointed out be very soon, is the implementation guidance.

Good Afternoon All. Just wade in on the debate re timelines, AI gives this response: "The Genedrive CYP2C19-ID test is part of a NICE pilot project aimed at optimizing antiplatelet therapy for stroke and transient ischemic attack (TIA) patients by identifying those who may not respond well to clopidogrel due to CYP2C19 gene variants. The pilot, running from October 2024 to April 2025, focuses on developing an efficient model for incorporating this genetic testing into stroke and TIA care." So I'm sure it was slightly delayed but delays are par for the course for Genedrive!

A reminder of the previous NICE guidance for CYP2C19 testing from July of last year:

"Use CYP2C19 genotype testing to assess if clopidogrel is a suitable antiplatelet drug for people who have just had an ischaemic stroke or a transient ischaemic attack (TIA).

When offering CYP2C19 genotype testing: take into account that the prevalence of different CYP2C19 genotypes may vary between ethnic groups

explain to the person having the test the possible implications of the results and give support and information.

Laboratory-based testing

Use laboratory-based testing for CYP2C19 genotype testing.

Point-of-care testing

Use the Genedrive CYP2C19 ID Kit point-of-care test for CYP2C19 genotype testing when laboratory-based testing is not available.

Use the Genomadix Cube point-of-care test when laboratory-based testing and the Genedrive CYP2C19 ID Kit point-of-care test are not available.

CYP2C19 point-of-care genotype testing is recommended only if quality-assurance processes and arrangements are in place."

As for GDR's MT-RNR1 ID Kit that is a no brainer as speed is of the essence.

One thing that came over from this forum is that the company seems not to be in the precarious state that the doom and gloom merchants would have us believe. It will be cash positive somewhere between 6 to 12 months according to company forecasts. Revenue is already be coming in from 14 NICUs and from the largest stroke centre in the country. It was confirmed that we should be getting the conclusion (ie how they intend to implement the national rollout as jlc pointed out) of the CYP2C19 pilot any day now. National rollout following that would bring substantial revenue. There is also the Scottish rollout starting in October. Early sales are forecast for Q1 2026 in Western Europe and the Middle East. The potential is staggering with near term serviceable opportunities in excess of £200 million. The only disappointment for me was that the FDA submission for MTRNR1 is not forecast until the end of 2026.

AIMHO

You mean, of course, 1 January 2026 - 30th June 2026-, but very positive in any case! 🙂

A useful forum. Some of the key points:

The two products are first to market and best in class. Backed by national and international clinical guidance that supports use of the tests and enables very significant patient outcomes.

Anticipate transitioning to EBITDA in H2 2026 (not end as some have stated).

CYP2C19 testing has £660 million global value and £170 million in the near to medium term target group.

MTRNR1 testing has global value of £330 million per annum and £65 million in the near to medium term target group.

In the UK £27 million pa potential, countries accepting CE IVD comes to £164 million pa potential and countries requiring specific internal regulatory compliance c £117 million pa potential.

As of now 14 NICUS within the UK using MTRNR1 which is 10% of the UK market.

FDA. Estimate end of 2026 for submission of MTRNR1.

Conclusion of pilot for CYP2C19 AROUND NOW.

Progressing to early sales in Western Europe and the Middle East in Q1 2026.

.

24/4/24: "genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, announces that it has entered into a Clinical Trial Agreement with a leading multi-state physician organisation ("Research Partner") in the USA to support clinical studies required for engagement with the U.S. Food and Drug Administration ("FDA") to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit into the USA via the FDA De novo submission process."

That sounds like a large company to me.

1)"Any mention of National roll out or National commissioning for either test has disappeared altogether from all company communications."

Not quite true. They were clearly over optimistic about the timeline but Gino did respond to a question at the IMC in December when asked about national commissioning for AIHL by April saying "We are confident of that". Delayed, yes, but clearly still anticipated.

2) "So, where can GDR find any money to continue?"

There is a tie up with a large American company. The FDA application could be funded by them. With national commissioning, sales here, plus sales to the EU and Middle East, should fund the UK operations.

3)"The numerous delays, one after the other, in NICE, NHS pilot schemes, FDA applications and even EU sales approvals all point to something a little more sinister."

Delays with all the stringent regulatory hurdles to work through are pretty common in the pharma industry.

4)"At best the Directors are totally incompetent and the company will go into administration"

As has been pointed out, the chairman has wide experience and has successfully sold multiple companies as going concerns. Also the directors bought a large quantity of shares in December. Would they have done so if the company was in danger of administration?

AIMHO

Thanks Jimi. A lot clearer now. The granting of either one should, IMO, mark a turning point in GDR's fortunes.

Hi Jimi, I'm still rather confused about the difference between national commissioning and special commissioning and what it would mean for GDR's tests in practical terms.

Ok, but in the event we've had neither!

Ok, but the company themselves had previously touted national commissioning as coming by April.